FDA Radiology AI Devices

PHAROS is a computed emission tomography system used in radiology to help clinicians obtain detailed three-dimensional images of the body. This technology assists in the diagnosis and monitoring of various medical conditions by providing high-quality images that aid in accurate assessment and treatment planning.

The uMI Panvivo is a system for performing computed emission tomography, which helps clinicians visualize and analyze internal structures in the body for diagnostic purposes. It supports advanced imaging techniques to assist medical professionals in detecting and assessing diseases.

The Biograph Vision and Biograph mCT PET/CT systems by Siemens are advanced imaging devices combining positron emission tomography (PET) and computed tomography (CT). These systems help clinicians detect and diagnose various conditions by providing detailed molecular and anatomical images, facilitating better patient management.

HeartSee Cardiac P.E.T. Processing Software is a tool that helps trained clinicians analyze heart PET images to quantify blood flow and heart function. It provides detailed maps and measurements that assist in diagnosing coronary artery disease by measuring myocardial perfusion and coronary flow reserve. This enables better clinical interpretation and patient management based on quantitative PET imaging data.

The uMI Panvivo is a PET/CT medical imaging system designed to provide combined anatomical and functional images for clinicians. It uses PET to show distribution of radiopharmaceuticals and CT to provide detailed anatomical information. The system supports assessment of metabolic and physiologic functions across various parts of the body including oncology, neurology, and infection imaging. It can also assist in treatment planning for radiotherapy and interventional radiology, improving diagnostic accuracy and patient care.

The uMI Panorama is a combined PET/CT diagnostic imaging system designed to assist healthcare professionals in detecting and evaluating diseases like cancer, heart, and neurological disorders. It fuses PET metabolic functional imaging and CT anatomical imaging with advanced AI algorithms to improve image quality, reduce artifacts, and enhance diagnostic confidence. It supports PET/CT and single modality CT imaging, including low dose CT lung cancer screening, providing comprehensive information for patient management.

The uMI Panvivo is a combined PET/CT imaging system designed to provide high-quality functional and anatomical images to help clinicians detect, localize, evaluate, and monitor abnormalities such as tumors, lesions, infections, and other conditions across various body areas. It supports better patient experience with a large bore and advanced iterative reconstruction algorithms aided by deep learning, improving image quality and diagnostic accuracy. Additionally, it assists in radiotherapy planning and interventional radiology procedures.

The uMI Panorama is a diagnostic imaging system combining PET and CT scans to provide both functional and anatomical information of the body. It helps healthcare professionals detect and evaluate diseases in oncology, cardiology, and neurology by offering fused metabolic and anatomical images. The device includes AI-based software updates to improve image reconstruction and analysis, enhancing diagnostic accuracy and patient management.

The uMI Panorama is a PET/CT system that provides combined metabolic and anatomical imaging to assist healthcare professionals in detecting, diagnosing, staging, and managing various diseases including oncology, cardiology, and neurology conditions. It supports both PET and standalone CT imaging and can be used for low dose CT lung cancer screening, enhancing patient care with fused functional and anatomical images.

Precision DL by GE Healthcare is a deep learning software designed to improve the quality of non-Time-of-Flight PET images used in clinical oncology. It enhances image contrast and reduces noise, helping clinicians obtain clearer PET scans to better detect and evaluate cancer, ultimately supporting improved patient care.